Prostatitis syndrome includes prostatitis by various pathologies and is a urological disease found in male adults in a relatively high frequency. Formerly, this disease was classified into acute bacterial prostatitis, chronic bacterial prostatitis, chronic nonbacterial prostatitis and prostatodynia (Drach et al., 1978) but, at present, the disease type classification newly proposed in 1999 by the National Institute of Health (NIH) has been widely used (Krieger, et al.). According to the new classification, prostatitis syndrome is classified into four groups of category I (acute bacterial prostatitis), category II (chronic bacterial prostatitis; CBP), category III (chronic prostatitis/chronic pelvic pain syndrome; CP/CPPS) (sometimes called chronic intrapelvic pain syndrome/prostate-related pain syndrome)) and category IV (asymptomatic inflammatory prostatitis). The correlation between old and new classifications is that acute bacterial prostatitis in the old classification corresponds to the category I of the new classification, chronic bacterial prostatitis in the old classification corresponds to the category II of the new classification and chronic nonbacterial prostatitis and prostatodynia in the old classification are integrated by the category III of the new classification. Further, in the category III, there are inflammatory one (category IIIA) and non-inflammatory one (category IIIB). Category IV of the new classification has no corresponding old classification and is a newly established one.
When there is just mentioned “chronic prostatitis” in the present application, it covers the category II (CBP) and the category III (CP/CPPS) in the above new classification. Although both have common symptom, it has been said that, in terms of frequency, the category III is far more than the category II.
On the other hand, there is interstitial cystitis (IC) which is a disease showing a lower urinary tract symptom such as frequent urination. This disease is mostly found in females and it has been said to be rare in males. As to chronic prostatitis (category III), there are reports that 60% thereof shows petechial hemorrhage due to hydrodistention of the bladder under anesthetization and that 84% of the case is positive in a potassium test which is a test for hyperpermeability of urothelium whereby the correlation to and overlap with interstitial cystitis is predicted.
Symptoms
In chronic prostatitis, pain of hypogastrium corresponding to perineal region, penis, scrotum or bladder, pain of pelvis such as ejaculatory pain or indefinite complaint such as urination disorder including micturition pain, residual urine, frequent urination or the like are typical symptoms. For judging the severity of chronic prostatitis and the therapeutic effect of the drug, there has been used the NIH Chronic Prostatitis Symptom Index (NIH-CPSI) which is stipulated by the NIH and is constituted of the question form for three domains, i.e. Pain or Discomfort, Urination and Quality of life (QOL).
On the other hand, in interstitial cystitis, interstitium results in inflammation and muscle of bladder shrinks. Therefore, bladder does not swell and urine only in an amount of not more than one half of normal bladder is able to be stored whereby the lower urinary tract symptom such as frequent urination, increased desire to urinate, urinary urgency or bladder pain is resulted. As mentioned above, there are many cases where chronic prostatitis (category III) and interstitial cystitis are unable to be discriminated by subjective symptom or urinary observation and they are often overlapped. Therefore, there are many cases where a patient is diagnosed as chronic prostatitis in spite of the fact that he/she is with interstitial cystitis or, conversely, a patient being initially diagnosed as chronic prostatitis is finally diagnosed as interstitial cystitis.
Therapy
Since there is a possibility that bacterial infection is a cause of the category II of chronic prostatitis, antibacterial chemotherapy is a main therapeutic method. Actually however, there are many cases which are resistant to the therapy and it is often that continuance of or change in antibacterial agent is necessary or that the following therapeutic agent for the category III is used together therewith.
On the other hand, with regard to the category III, the cause of its onset is still ambiguous even at present and there is no definite therapeutic method. Accordingly, in the therapy of the category III, abundant and various therapeutic methods are tried with a presumption that various causes and pathologies such as retention of prostatic fluid, participation of autoimmune or allergy, participation of mycoplasma or chlamydia, imbalance of sexual hormones or psychological factor are in the background. Examples thereof include the therapy using various medicaments such as antibacterial agent (newquinolone type and tetracycline type), al blocker (tetrazocine, tamsulosin and alfuzosin), plant preparation (cernitin pollen extract), nonsteroidal anti-inflammatory drugs [NSAIDs] (celecoxib), anti-anxiety agent (diazepam) or Chinese herbal medicine; massage of prostate; thermotherapy; acupuncture; and microwave therapy via urinary tract. However, the efficacy rate in any of them is said to be about 50 to 60%.
In the category III, there are the cases where a plurality of factors are complicated or where transfer from the category II to the category III takes place whereby symptom and therapy of the category III become more complex. As such, chronic prostatitis (categories II and III) is a long-sustaining intractable disease showing resistance to various therapies and is the disease having many clinical problems. In view of the current status as mentioned above, there has been a strong demand from the actual clinical fields for the medicament which is effective for chronic prostatitis.
On the other hand, interstitial cystitis is also a disease where the cause has not been clarified yet. Since it is not resulted by bacteria, antibiotic substances are ineffective. The therapy therefor is usually conducted by combining several means such as hydrodistention of the bladder, intravesical instillation of dimethyl sulfoxide (DMSO) or drug therapy. As to the medicament, antidepressant, antihistaminic agent, etc. are used. Object of the therapy is not to completely cure but its target is alleviation/disappearance of the symptom.
The extract from inflamed tissues inoculated with vaccinia virus as an active ingredient in the ameliorating or therapeutic agent for chronic prostatitis, interstitial cystitis an/or urination disorders of the present invention (hereinafter referred to as “the medicinal agent of the present invention”) is disclosed to have the following effects: an analgesic effect, sedative effect, anti-stress effect and anti-allergic effect (see Patent Document 1); an immunostimulating effect, anti-cancer effect and cirrhosis inhibitory effect (see Patent Document 2); a treatment effect against idiopathic thrombocytopenic purpura (see Patent Document 3); a treatment effect against postherpetic neuralgia, brain edema, dementia, spinocerebellar degeneration and the like (see Patent Document 4); a treatment effect against Raynaud syndrome, diabetic neuropathy, sequelae of subacute myelo-optico-neuropathy and the like (see Patent Document 5); a kallikrein production inhibitory effect and peripheral circulatory disorder improving effect (see Patent Document 6); a bone atrophy improving effect (see Patent Document 7); a nitric oxide production inhibitory effect effective for the treatment of sepsis and endotoxic shock (see Patent Document 8); a treatment effect against osteoporosis (see Patent Document 9); a treatment effect against AIDS based on a Nef action inhibitory effect and chemokine production inhibitory effect (Patent Documents 10 and 11); a treatment effect against ischemic disorders such as cerebral infarction (Patent Document 12); a treatment effect against fibromyalgia syndrome (Patent Document 13); and a treatment effect against infections (Patent Document 14); prophylactic or alleviating effect for a peripheral nerve disorder induced by an anti-cancer agent and the like. However, it is not known that the extract from inflamed tissues inoculated with vaccinia virus as an active ingredient in the medicinal agent of the present invention is effective for amelioration or therapy of chronic prostatitis, interstitial cystitis an/or urination disorders.